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Mainz Biomed Announces US Extension of ColoFuture Study To Evaluate Integration of Novel mRNA Biomarkers Into ColoAlert

Schematic of human intestines.
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Mainz Biomed NV (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, has announced the initiation of eAArly DETECT, its US extension of ColoFuture, the Company’s European feasibility study evaluating the integration of a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert, Mainz’s highly efficacious, and easy-to-use detection test for colorectal cancer (CRC) being commercialized across Europe and in select international territories. ColoFuture/eAArly DETECT are multi-center studies assessing the potential of these biomarkers to identify advanced adenomas, a type of pre-cancerous polyp often attributed to CRC.

“We are excited by the opportunity to expand the ColoFuture study to the U.S. as it enables us to accelerate the timeline to evaluate the potential of these biomarkers to be incorporated into our U.S. pivotal study, which is on track to initiate later this year,” commented Guido Baechler, chief executive officer of Mainz Biomed. “The combinatory U.S. and European studies represent groundbreaking work in the field, as the potential inclusion of advanced adenomas in ColoAlert’s technical profile will represent a transformational advancement in self-administered CRC screening.”

Five novel gene expression (mRNA) biomarkers were in-licensed from the Université de Sherbrooke, Quebec, Canada, in early January 2022. In the institution’s pioneering work, researchers tested a battery of novel transcriptional biomarkers using colon cancer samples and precancerous lesions. The five mRNA targets chosen by Mainz Biomed provided the greatest sensitivity and specificity of detection (Herring et al. 2021) and demonstrated a unique ability to identify curable precancerous colonic polyps, as well as treatable early-stage CRC. The eAArly DETECT study will evaluate the effectiveness of these biomarkers to enhance ColoAlert’s product specifications to extend its capability to include the identification of advanced adenomas while increasing ColoAlert’s rates of diagnostic sensitivity and specificity.

The Company expects to complete enrollment in Q1 2023 and targets reporting topline results in 1H 2023. Based on the study’s outcome, Mainz Biomed will determine if any biomarkers are eligible for inclusion in the Company’s US pivotal study, which is on track to initiate in Q4 2022.